Developing a Compliant QMS for FDA (QSR and ISO 13485/9001)

This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA QS requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and as a necessary step to market their products globally.

During this webinar we will discuss the documentation process, and implementing a management system to meet the requirements of ISO and QSR and the operational objectives of the company

This course will provide guidance on best practices for developing a compliant QMS. We will explore strategies for dealing with common documentation and compliance issues. The course also summarizes the essential documentation requirements and gives an introduction to the key elements for implementation of a compliant system.

Areas Covered in the Session :
Understand the Quality Management Principles
Discuss the benefits of an effective QMS
Review the Quality Essentials
Procedure Development
Understand the required documentation:
Quality Manual
Policies
Procedures
Work Instructions
Identifying Exempt sections & how to document
Managing and maintaining your QMS

Who Will Benefit:
Quality Associates
New Quality Assurance Managers
ISO 13485/9001 Implementation Team Members,
Management Representatives

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance